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2023-03-08 16:03:15 By : Ms. Anna Xu

A newsletter briefing on the health-care policy debate in Washington.

with research by McKenzie Beard

A newsletter briefing on the health-care policy debate in Washington.

Good morning, where we’re one day closer to a one-week congressional recess. Tell us what else you’re watching next week: rachel.roubein@washpost.com. 

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Today’s edition: FDA advisers unanimously recommended the agency allow an opioid overdose reversal drug be sold over-the-counter. Congressional scorekeepers predict a rise in spending on Social Security and health care. But first … 

Sen. Bernie Sanders (I-Vt.) is hauling his first pharma CEO to Capitol Hill. 

In a hearing next month, the new chair of the Senate’s sweeping health panel is planning to publicly grill Stéphane Bancel, the top executive at Moderna, about the company’s reported plan to more than quadruple the price of its coronavirus vaccine, our colleague Liz Goodwin reports. 

Sanders has pledged to use his new perch as Senate HELP Committee chair to move “very aggressively” on the high cost of prescription drugs. The hearing foreshadows the independent firebrand’s approach to his new position with the pharmaceutical industry expected to be caught in his crosshairs time and time again. His rhetoric could put pressure on companies to attempt new ways of boosting access to drugs or making medications more affordable, though legislation aimed at drugmakers won’t pass in a divided Congress.

Sanders is particularly incensed at Moderna, arguing the drugmaker is the “poster child” for greed within the pharmaceutical industry. The company’s only federally approved drug is the coronavirus vaccine, which it received billions in direct federal funds to develop. 

The hearing is slated for March 22 and will consist of two panels.

Up first is Bancel, who agreed to testify without being subpoenaed. Forbes puts his net worth at more than $5 billion, and Sanders plans to argue that Bancel and several other Moderna executives “profited” off the pandemic.

The second panel includes Christopher Morten, of Columbia Law School; Ameet Sarpatwari, of Harvard Medical School; and Craig Garthwaite, of Northwestern University.

The view from Moderna: The company said in a statement yesterday that it “remains committed” to making sure Americans will have access to the vaccine no matter their ability to pay. (More on that later.) The company previously told The Health 202 that it was “committed to pricing that reflects the value that covid-19 vaccines bring to patients, health-care systems and society.”

Some news: Moderna CEO Stephane Bancel has agreed to appear before the HELP committee, chaired by Bernie Sanders, next month https://t.co/qWmSr7LvsI

Sanders believes he’ll get buy-in from Republicans in his quest to focus on pharmaceutical greed. Yet, it’s highly unlikely they’ll have the same tune as the self-described democratic socialist who frequently rails against the drug industry in hearings and on the Senate floor. 

Earlier this year, Sen. Bill Cassidy (La.) — the health committee’s ranking Republican — told The Health 202 that he wanted to hear more from Pfizer and Moderna before passing judgment on their decisions to hike prices. 

In the Capitol yesterday, Sen. Mitt Romney (R-Utah) said he wanted to ask Bancel about the “progress of pharmaceutical innovation” in the country, and how U.S. prices compare with other nations. Sen. Rand Paul (R-Ky.) — who sits on the panel and has staked out an increasingly skeptical posture on vaccines — said he was “in favor” of Sanders’s move to bring Bancel in front of the panel. He declined to detail what questions he planned to ask the Moderna executive. 

There is the possibility that some members of the committee will use the Moderna hearing to sow doubts about the vaccines, which Sanders acknowledged to Liz.

The federal government has been purchasing coronavirus vaccines, making them free to all Americans throughout the pandemic. That will change at some point this year, as the Biden administration will shift payment and procurement of the shots to the commercial market. 

Such a move wouldn’t affect those with insurance, but it has raised concerns about how the uninsured will be able to afford and access the vaccines. 

That would have likely been a big question at the March hearing. But since the company’s CEO agreed to appear in front of the Senate health committee, Moderna announced a “patient assistance program” that will provide coronavirus vaccines free to the uninsured or underinsured. A company spokesman said the looming hearing didn’t play a role in the decision to create the new program. 

Similar to Moderna, Pfizer is considering pricing its vaccine at $110 and $130 on the commercial market. A company spokeswoman said eligible U.S. residents without insurance will also be able to access the coronavirus vaccine for free through a patient assistance program, and both companies declined to share details on what such programs would look like.

For the administration’s part … Ashish Jha, White House covid czar, tweeted that “We are committed to ensuring that vaccines and treatments are accessible and not prohibitively expensive for uninsured Americans.” But the White House also hasn’t released a plan, so it’s unclear how such a program would operate. 

Ashish Jha, White House covid czar:

At some point (likely over the summer or early fall) We will transition from US government distributed vaccines and treatments To those purchased through the regular healthcare system The way we do for every other vaccine and treatment What happens after that? 3/n

Emergent BioSolutions’s opioid overdose reversal drug naloxone should be approved for over-the-counter use, a panel of Food and Drug Administration advisers recommended yesterday.

The unanimous endorsement follows a full day of discussions centered on the safety of the product, called Narcan, and whether consumers could correctly administer it in an emergency situation. Making Narcan available without a prescription has been urged by doctors, advocates and the Biden administration as a critical tool to combat the country’s opioid epidemic.

Advisers gave the greenlight despite concerns raised by some panelists about the drug’s labeling and instructions, which led to user errors in a company study. Ultimately, though, advisers agreed that the urgency of the nation’s devastating overdose crisis outweighs delaying the approval process to run user-friendliness tests on the new instructions, Stat’s Lev Facher reports.

The timeline: The panel’s recommendation now heads to the FDA, which is expected to issue a final decision by March 29. If the agency concurs with its advisers next month, as it typically does, the nasal spray will likely hit the shelves later this summer, according to a company spokesperson who didn’t share details on the price.

Keeping Narcan with you can save a life. The FDA should accept the recommendation to make it available over the counter. We must guarantee that it is affordable and accessible whenever and wherever people need it.

The federal government’s spending on Social Security and Medicare will rise significantly over the next decade, according to new estimates from the nonpartisan Congressional Budget Office that add mounting pressure on lawmakers as the programs hurtle to future insolvency.

The details: CBO analysts estimate that the federal government’s spending on Social Security and health care will nearly double by 2033, increasing from $1.2 trillion to $2.4 trillion and from $1.4 trillion to $2.7 trillion, respectively, according to the Committee for a Responsible Federal Budget, which advocates for deficit reduction.

The increase in spending is being driven by several factors, including rising health-care costs for Medicare beneficiaries, Social Security’s new cost-of-living adjustment and high inflation rates. Also, the rate of Americans reaching retirement age and joining the programs is growing faster than the number of younger people paying into them, the CBO said.  

The projections released yesterday also came with a warning: The United States is at risk of defaulting on its debt between July and September if Congress fails to raise or suspend the nation’s borrowing cap in time, The Post’s Tony Romm reports.

The new estimates will almost certainly contribute to the partisan standoff over federal spending currently being waged on Capitol Hill. President Biden has sought to cast Republicans as seeking to cut entitlement programs, while House Speaker Kevin McCarthy (R-Calif.) has vowed that reductions are “off the table” in the debt ceiling fight. Meanwhile, the programs are inching closer to financial insolvency — prompting some experts to call for bipartisan action to keep them afloat.

$20T in additional projected debt (#CBO) illustrates the absurdity of Biden’s attempt to refuse to negotiate on the debt ceiling, which literally exists to control debt… the Ante has been raised. #CutSpending #StandUpForAmerica

Doctors at Florida hospital say patient care has suffered since HCA's cost cuts (By Gretchen Morgenson, Anna Schecter and Cynthia McFadden | NBC News)

Doctors’ top lobbyist in Washington on Medicare money, burnout, and private equity (By Sarah Owermohle | Stat)

Governments target medical debt with COVID relief funds (By Mark Pratt | The Associated Press)

[social gathering] guy: wow, you work in an ER? me: yep guy: [whispering] so, uh, what's the craziest thing you've seen in the ER? me: [whispering back] a dermatologist with a zit

Thanks for reading! See y'all tomorrow.